REFRESH OPTIVE Advanced

Product NDC: 0023-4491
11-digit product format: 000234491
Labeler code: 0023
Product ID: 0023-4491_74f3d119-623c-4bd1-a5aa-e92db774f116
Type: HUMAN OTC DRUG
Nonproprietary name: carboxymethylcellulose sodium, glycerin, polysorbate 80
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-15
Substance: CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80
Active strength: 5; 10; 5 mg/mL; mg/mL; mg/mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0023-4491	0023-4491-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0023-4491	0023-4491-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: REFRESH OPTIVE Advanced
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOXYMETHYLCELLULOSE SODIUM	5 mg/mL
GLYCERIN	10 mg/mL
POLYSORBATE 80	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K679OBS311	Internal UNII lookup
PDC6A3C0OX	Internal UNII lookup
6OZP39ZG8H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1241471	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ebd0839e-2e1d-4e0e-986c-19f1f5c76358	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098	Product name	2	20240205
e2f276e5-439f-b432-b5e5-b0cfa993da69	Product name	3	20220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0023-4491-05	REFRESH OPTIVE Advanced	0.4 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.4	11
0023-4491-05	REFRESH OPTIVE Advanced	5 in 1 CARTON	SOLUTION/ DROPS	5	11
0023-4491-30	REFRESH OPTIVE Advanced	30 in 1 CARTON	SOLUTION/ DROPS	30	11
0023-4491-30	REFRESH OPTIVE Advanced	0.4 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-4491-30	EA - Each	0023-4491	95847a4a-09ea-46e7-8122-8f177a6123aa	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
carboxymethylcellulose sodium	ACTIVE INGREDIENT	K679OBS311	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
polysorbate 80	ACTIVE INGREDIENT	6OZP39ZG8H	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
carboxymethylcellulose	ACTIVE MOIETY	05JZI7B19X	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
glycerin	ACTIVE MOIETY	PDC6A3C0OX	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
polysorbate 80	ACTIVE MOIETY	6OZP39ZG8H	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
carbomer copolymer type A	INACTIVE INGREDIENT	71DD5V995L	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
erythritol	INACTIVE INGREDIENT	RA96B954X6	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
levocarnitine	INACTIVE INGREDIENT	0G389FZZ9M	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-4491	REFRESH OPTIVE ADVANCED (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]	10	Current NDC, Legacy NDC, 4 package rows	20241207_ebd0839e-2e1d-4e0e-986c-19f1f5c76358.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Eyes Natural Tears	POLYVINYL ALCOHOL AND POVIDONE	Prestige Brands Holdings, Inc.	efba3eb0-798d-4635-b19b-4970e45b3cc9	2024-04-01	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol	POLYVINYL ALCOHOL	A-S Medication Solutions	c77589fd-f68d-48b7-bd12-51f6b4cc9402	2024-03-20	Warnings	Exact identifier application number: M018
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier application number: M018
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier application number: M018
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier application number: M018
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort, CVP	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS	Lil' Drug Store Products, Inc.	0f50bcc8-3658-8c2c-e063-6294a90a8e13	2024-01-19	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier application number: M018
Exchange Select Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Army and Air Force Exchange Service	318bc025-c936-a066-e063-6294a90a4712	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Original	TETRAHYDROZOLINE HCL	The Kroger Co.	318c17a1-fe08-508b-e063-6394a90a2e08	2024-01-01	Warnings	Exact identifier application number: M018
HEB Original Eye Drops	TETRAHYDROZOLINE HCL	HEB Grocery Company, LP	318cb457-bb2d-a1ee-e063-6294a90a8019	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart, Inc.	318dc92a-0707-d6a4-e063-6294a90ab78a	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	The Kroger Co.	318dea21-2656-36a3-e063-6294a90ac9c4	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Original	TETRAHYDROZOLINE HCL	Harris Teeter, LLC.P	31a1b962-27ad-97b1-e063-6294a90a77f1	2024-01-01	Warnings	Exact identifier application number: M018
CVP Sterile Eye Drops	TETRAHYDROZOLINE HCL	Salado Sales, Inc.	31a216f8-28e9-ec8f-e063-6394a90aec49	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Sterile Eye Drops	TETRAHYDROZOLINE HCL	United Natural Foods, Inc.	31a25efb-a627-1a13-e063-6394a90a2ca3	2024-01-01	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Original	TETRAHYDROZOLINE HCL	Valu Merchandisers Company	31a2a42a-bcfe-4f22-e063-6294a90ac60e	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Original	TETRAHYDROZOLINE HCL	Discount Drug Mart, Inc.	31a2efb2-3924-6a12-e063-6394a90ab0e2	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Redness Relief Lubricant Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	United Natural Foods, Inc	31a30b00-9f4b-717a-e063-6394a90a8a87	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC.	31a3d575-10f1-5feb-e063-6294a90ac478	2024-01-01	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
6OZP39ZG8H	POLYSORBATE 80	9005-65-6	POLYSORBATE 80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1241471	carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution	PSN	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	11
1241471	carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic Solution	SCD	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	11
1241471	carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic Solution	SY	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-4491-05	00023449105	5 VIAL, SINGLE-USE in 1 CARTON (0023-4491-05) / .4 mL in 1 VIAL, SINGLE-USE	2013-01-15	0000-00-00	Yes	No	Current
0023-4491-30	00023449130	30 VIAL, SINGLE-USE in 1 CARTON (0023-4491-30) / .4 mL in 1 VIAL, SINGLE-USE	2013-01-15	0000-00-00	No	No	Current